SmPC- Salbutamol Tablets BP 2mg: Change history
View Summary of Product Characteristics (SmPC- Salbutamol Tablets BP 2mg)
Last updated on this site: 30 Jan 2026
IA, B.II.c.3.z Change in source of excipient unlikely to present any risk of TSE contamination - Pink colourant change from DISPERSED PINK 15123 to PIGMENT BLEND PB-240054 PINK. Consequential updates to Leaflets and SPC sections 6.1. [impl. date: 30/12/2025]
Editorial updated of Module 3 sections - sulph to sulf.
Last updated on this site: 30 Jan 2026
IA, B.II.c.3.z Change in source of excipient unlikely to present any risk of TSE contamination - Pink colourant change from DISPERSED PINK 15123 to PIGMENT BLEND PB-240054 PINK. Consequential updates to Leaflets and SPC sections 6.1. [impl. date: 30/12/2025]
Editorial updated of Module 3 sections - sulph to sulf.
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Changes: (Updated: 30 Jan 2026)
IA, B.II.c.3.z Change in source of excipient unlikely to present any risk of TSE contamination - Pink colourant change from DISPERSED PINK 15123 to PIGMENT BLEND PB-240054 PINK. Consequential updates to Leaflets and SPC sections 6.1. [impl. date: 30/12/2025]
Editorial updated of Module 3 sections - sulph to sulf.
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Changes: (Updated: 07 Nov 2025)
Update in line with MHRA request to add sleep disturbances as a side effect to section 4.8 of the product SmPC, and to section 4 of the product PIL.
SmPC sections updated: 4.8 and 10
Variation Approval 03/11/2025
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Changes: (Updated: 21 Sep 2022)
initial upload